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A Prospective Observational Study Using the FAM-CAM

Recruitingn/aAges 18 Years - anyAllShanghai Zhongshan Hospital
NCT07694687 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn whether family members can help identify signs of delirium in adult patients who are staying in the intensive care unit. Delirium is a sudden change in attention, thinking, or awareness that can happen during serious illness. The main question it aims to answer is: Can family members notice possible signs of delirium that may not be found during routine ICU delirium screening? Participants will receive their usual medical care. Family members who know the patient well will complete a short delirium assessment called the FAM-CAM after visiting the patient. Nurses will continue to perform routine ICU delirium screening using the ICDSC as part of usual care. The study team will compare the family member's assessment with the nurse's routine assessment to see whether family observations provide additional helpful information. Family members

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📋 Eligibility rules (as published)
Inclusion Criteria Patients: * Aged 18 years or older. * Admitted to the ICU for at least 24 hours. * Richmond Agitation-Sedation Scale (RASS) score ≥ -3 at the time of enrollment. * Provided written informed consent to participate. When patients were unable to provide consent, consent was obtained from their legal surrogates. Family Members: * Aged 18 years or older. * Identified as the patient's primary family caregiver. * Had visited the patient in the ICU at least once. * Were able to understand and communicate in Mandarin. * Provided written informed consent and voluntarily agreed to participate. Exclusion Criteria Patients: * Persistent coma or deep sedation throughout the ICU stay, defined as Glasgow Coma Scale (GCS) score ≤ 8 or RASS score of -4 or -5. * A previously confirmed diagnosis of dementia, a severe psychiatric disorder, or an organic neurological disease. * Severe hearing impairment that prevented effective communication or study participation. Family Members: -Significant visual, hearing, or cognitive problems that prevented them from understanding the study procedures or completing the study assessments.
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What it tests

  • Not listed
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Where

1 site
Zhongshan Hospital, Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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